Device to block emesis and reflux and associated system and method

ABSTRACT

A nasogastric/orogastric (Ng/Og) device includes a main lumen configured for at least one of gastric decompression, enteral feeding and enteral medication administration. An expandable esophageal cuff is carried by the device body and configured in a normally expanded position such that when inserted within the esophagus, the esophageal cuff conforms to the interior surface of the esophagus and emesis and/or reflux is blocked from passing out of the stomach and past the esophageal cuff. A vacuum lumen is carried by the device body and connected to the expandable esophageal cuff. When vacuum is applied, the esophageal cuff is contracted against the device body to permit the device to be inserted and placed within the esophagus. When the vacuum is released, the esophageal cuff expands against the interior surface of the esophagus.

RELATED APPLICATION(S)

This application is a continuation-in-part application of patentapplication Ser. No. 13/767,922, filed Feb. 15, 2013, the disclosure ofwhich is hereby incorporated by reference in its entirety.

FIELD OF THE INVENTION

This invention is related to the field of medical devices, and moreparticularly, this invention is related to a device for blocking emesisand/or reflux and a system of diagnosing a physiological abnormality ina patient by inducing an involuntary reflex cough test (iRCT).

BACKGROUND OF THE INVENTION

Commonly assigned U.S. application Ser. No. 13/354,100 filed Jan. 19,2012 by the same inventors, the disclosure which is hereby incorporatedby reference in its entirety, discloses a system and method ofdiagnosing acid reflux using an involuntary reflex cough test. In oneexample as disclosed, a nasogastric/orogastric (Ng/Og) device isinserted though the mouth or nose and through the esophagus and into thestomach and the involuntary reflex cough epoch induced. Theintra-abdominal pressure and elevational reflux along the Ng/Og deviceis measured. In an example, the functional status of the gastric valveis determined based on the measured intra-abdominal pressure andelevational reflux along the catheter. This procedure is sometimes alimited analysis that is not always accurate to determine whether thereis a reflux problem, and thus, requiring an Ng/Og device, which in somecases can interfere with the gastric valve and the lower esophagealsphincter. In another example, an Ng/Og device with an esophageal cuffis used. A sequence of steps occur, e.g., inflating the esophageal cuff,inducing the involuntary reflex cough epoch, determining if acid refluxhas occurred, deflating the esophageal cuff, and again inducing theinvoluntary reflex cough epoch. Results are analyzed to determine thefunctional status of the gastric valve.

Use of the involuntary reflex cough test with or without a voluntarycough test is also disclosed in commonly assigned U.S. patentapplication Ser. No. 11/608,316 filed Dec. 8, 2006; Ser. No. 11/550,125filed Oct. 17, 2006; Ser. No. 12/643,134 filed Dec. 21, 2009; Ser. No.12/643,251 filed Dec. 21, 2009; Ser. No. 12/878,257 filed Sep. 9, 2010;Ser. No. 12/878,281 filed Sep. 9, 2010; and Ser. No. 12/878,316 filedSep. 9, 2010; the disclosures which are all hereby incorporated byreference in their entirety. The '257, '281 and '316 applicationsdisclose nasogastric/orogastric (Ng/Og) devices, some with or withoutesophageal cuffs and/or reflux measurement systems that can be used toassess GERD or determine stress urinary incontinence or otherphysiological abnormalities using the involuntary reflex cough testsalone or in combination with the voluntary cough test.

These applications also disclose summary results when the involuntaryreflex cough test is induced. In one embodiment, a handheld or otherprocessing device processes the test results. Various urinary bladdercatheters are also disclosed that may include various indicators. Inanother example, the Ng/Og device includes an esophageal cuff carried bythe device and positioned in the esophagus to reduce or diminish gastricreflux and/or emesis in surgical, neurological and/or trauma patients.These applications also disclose further developments regarding use ofthe involuntary reflex cough test.

Commonly assigned U.S. patent application Ser. Nos. 13/456,841 and13/456,882, the disclosures which are hereby incorporated by referencein their entirety, disclose systems and methods that test the gastricvalve and urethral sphincter. A contrast agent is administered into theesophagus of a patient followed by inducing an involuntary reflex coughepoch to isolate the gastric valve from the Lower Esophageal Sphincter(LES). In an example, it is possible to isolate the external urethralsphincter from the internal urethral sphincter. An imaging sensordetects the flow of the contrast agent during the involuntary reflexcough epoch and determines whether stomach reflux occurred indicative ofa malfunctioning gastric valve. A determination may be made if urineleakage occurs indicative of Stress Urinary Incontinence (SUI). In thesetypes of tests an emesis and reflux blocking can be important andimproved devices that block emesis and/or reflux and during theinvoluntary reflex cough test are desirable.

SUMMARY OF THE INVENTION

A nasogastric/orogastric (Ng/Og) device includes an elongate device bodyhaving a distal end for insertion into the stomach through the esophagusand a proximal end. A main lumen extends the length of the body and isconfigured for at least one of gastric decompression, enteral feedingand enteral medication administration. An expandable esophageal cuff iscarried by the device body mid-esophagus and configured in a normallyexpanded position such that when inserted within the esophagus, theesophageal cuff conforms to the interior surface of the esophagus andemesis and/or reflux is blocked from passing out of the stomach and pastthe esophageal cuff. A vacuum lumen is carried by the device body andconnected to the expandable esophageal cuff. When vacuum is applied, theesophageal cuff is contracted against the device body to permit thedevice to be inserted and placed within the esophagus. When the vacuumis released, the esophageal cuff expands against the interior surface ofthe esophagus.

In one example, the expandable esophageal cuff is formed as a flexiblesheath having an upper edge secured onto the device body. In anotherexample, an expandable balloon is secured onto the device body under theflexible sheath and attached thereto. A foam material is containedwithin the balloon that is compressed when vacuum is applied such thatthe flexible sheath contracts against the device body. In anotherexample, the flexible sheath includes a lower edge secured onto thedevice body and forms an expandable balloon. A foam material is withinthe balloon and is compressed when vacuum is applied such that theflexible sheath contracts against the device body.

In another example, at least one pressure sensor is located on thedevice body and configured to measure pressure in at least one of theupper esophagus, lower esophagus, and stomach. This at least onepressure sensor is formed a pressure transducer and a transducer leadconnecting the pressure transducer. In another example, at least one pHsensor is carried by the device body. In another example, the esophagealcuff is radio-opaque to aid in placement of the esophageal cuff at apredetermined location within the esophagus. In another example, asuction lumen is formed within the device body and suction portscommunicate with the suction lumen and are configured to permit suctionwithin the esophagus. The suction ports may be configured as one-wayvalves to permit suction for emesis and/or reflux into the suction lumenwhen a vacuum is drawn therethrough. A sump port may be positioned atthe distal end and a sump lumen formed the length of the device body andconfigured for venting gas and preventing adherence of the deviceagainst the gastric wall. A nebulizer lumen may extend along the devicebody and comprise a port through which medication is delivered foradministrating an involuntary reflex cough test. The esophageal cuffprotects the airway during the involuntary reflex cough test.

A system for diagnosing a patient for a physiological abnormality whileprotecting their airway is also disclosed. It includes the Ng/Og deviceand at least one electromyogram (EMG) pad configured to be attached tothe lumbar region of a patient's back and obtain an EMG from aninvoluntary cough activated paraspinal muscles. A processing device isconfigured to receive the EMG and process same to determine aphysiological abnormality. In one example, the portable device includesa housing configured for handheld use, at least one interface carried bythe housing and configured to receive any measurements obtained duringthe involuntary cough reflex test and a processor carried by the housingand connected to the interface and configured to receive themeasurements.

In another example, a device to block emesis and/or reflux includes atube insertable within the esophagus. An expandable esophageal cuff iscarried by the tube and configured in a normally expanded position suchthat when inserted within the esophagus, the esophageal cuff conforms tothe interior surface of the esophagus and emesis and/or reflux isblocked from passing out of the stomach and past the esophageal cuff. Avacuum lumen is formed from within the tube and connected to theexpandable esophageal cuff. When vacuum is applied, the esophageal cuffis contracted against the tube to permit the device to be inserted andplaced within the esophagus, and when the vacuum is released, theesophageal cuff expands against the interior surface of the esophagus.

A method aspect is also disclosed of inserting the Ng/Og device throughthe esophagus and followed by applying a vacuum within the vacuum lumento contract the esophageal cuff against the device body to permit thedevice to be inserted and placed within the esophagus. The vacuum isreleased and the esophageal cuff expands against the interior surface ofthe esophagus and engages the esophageal wall to block emesis and/orreflux from the stomach passing into the esophagus past the valve toprotect a patient's airway during an involuntary reflex cough event. Anebulized medication is administered to the patient to activate aninvoluntary reflex cough event and a physiological condition of apatient is sensed during the involuntary reflex cough event andprocessed to determine a physiological abnormality. Sensing thephysiological condition may be made by obtaining an EMG from involuntarycough activated paraspinal muscles and sensing intra-abdominal pressure(IAP) from a sensor carried by the device body and correlating the EMGand IAP with the involuntary reflex cough event to determine aphysiological abnormality.

BRIEF DESCRIPTION OF THE DRAWINGS

Other objects, features and advantages of the present invention willbecome apparent from the detailed description of the invention whichfollows, when considered in light of the accompanying drawings in which:

FIG. 1 is a diagrammatic view of a patient and showing the device inaccordance with a non-limiting example inserted through the mouth intothe esophagus and the valve positioned below the aortic notch.

FIG. 2 is a fragmentary plan view of a single lumen passive device inaccordance with a non-limiting example and showing a passive valve in aclosed position.

FIG. 3 is a fragmentary plan view of the device shown in FIG. 2 andshowing the passive valve in an open position.

FIG. 4 is an enlarged plan view of the passive valve and showing asecurement maintaining the passive valve in a closed position inaccordance with a non-limiting example.

FIG. 5 is a plan view of the passive valve shown in FIG. 3 and in anopened configuration.

FIG. 6 is an enlarged sectional view taken along line 6-6 of FIG. 5 andshowing a sliding ring that may be used as a securement in accordancewith a non-limiting example.

FIG. 7 is a fragmentary plan view of a dual lumen device similar to thesingle lumen device shown in FIG. 3 and showing a balloon positioned atthe distal end.

FIG. 8 is another fragmentary plan view of the dual lumen device similarto that shown in FIG. 7 and showing a sensor at the distal end.

FIG. 9 is an enlarged plan view of the distal end of the device in FIG.8 and showing a suction port and sensor.

FIG. 10 is a fragmentary plan view of a triple lumen device showing anopened passive valve and a balloon positioned at the distal end inaccordance with a non-limiting example.

FIG. 11 is an enlarged plan view of the opened passive valve shown inFIG. 10.

FIG. 12 is an enlarged plain view of the balloon shown in FIG. 10.

FIG. 13 is a partial sectional view taken along line 13-13 of FIG. 11.

FIG. 14 is a sectional view taken along line 14-14 of FIG. 12.

FIG. 15 is a sectional view taken along line 15-15 of FIG. 11.

FIG. 16 is a fragmentary plan view of a quad lumen device that mayinclude an additional lumen for suction above the valve or for otherpurposes.

FIG. 17 is an enlarged plan view of the passive valve shown in FIG. 16.

FIG. 18 is an enlarged plan view of the balloon shown in FIG. 16.

FIG. 19 is a fragmentary plan view of an active emesis containmentdevice having an active valve that includes an inflatable ballooncarried by the tube under the flexible sheath to open the valve uponinflation of the balloon in accordance with a non-limiting example.

FIG. 20 is a sectional view of the device taken along line 20-20 of FIG.19.

FIG. 21 is a fragmentary view of a triple lumen, active device similarto that active device shown in FIG. 19 and showing a balloon at thedistal end.

FIG. 22 is an enlarged plan view of the active valve shown in FIG. 21.

FIG. 23 is an enlarged plan view of the balloon shown in FIG. 21.

FIG. 24 is a fragmentary plan view of another embodiment of the devicethat uses an alternate configuration of an active valve with a differentballoon configuration.

FIG. 25 is an enlarged plan view of the active valve shown in FIG. 24.

FIG. 26 is a sectional view of the active valve taken along line 26-26.

FIG. 27 is a sectional view of the active valve taken in the directionof line 27-27 of FIG. 25.

FIGS. 28 and 29 show an example six-channel system for a processingdevice such as a portable handheld device, including a schematic circuitdiagram in FIG. 29 and block diagram in FIG. 28.

FIGS. 30A through 30F are figures showing an embodiment of annasogastric/orogastric (Ng/Og) device and having a nebulizing, pHsensing and pressure sensing function and an active valve such as shownin the embodiments of FIGS. 19-27.

FIGS. 31A through 31F are views similar to those shown in FIGS. 30A-30Fbut showing instead a device configuration with a passive instead ofactive valve.

FIG. 32 is a sectional view of another embodiment of the device similarto that shown in FIG. 20, but showing an expandable esophageal cuff thatincludes a vacuum lumen for contracting the esophageal cuff against thedevice body.

FIG. 33 is another embodiment similar to that shown in FIG. 26 andshowing use of the vacuum lumen similar to the vacuum lumen shown inFIG. 32.

FIG. 34 is yet another embodiment showing use of a vacuum lumen.

FIGS. 35A-35F are figures showing an embodiment of anasogastric/orogastric (Ng/Og) device with various functions that can beused with the embodiments shown in FIGS. 32-34.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Different embodiments will now be described more fully hereinafter withreference to the accompanying drawings, in which preferred embodimentsare shown. Many different forms can be set forth and describedembodiments should not be construed as limited to the embodiments setforth herein. Rather, these embodiments are provided so that thisdisclosure will be thorough and complete, and will fully convey thescope to those skilled in the art.

As will be described in detail below, FIGS. 2-18 illustrate a passiveemesis containment system formed in this example as a nasogastric (Ng)tube having a passive valve and FIGS. 19-27 illustrate an active emesiscontainment system as a nasogastric (Ng) tube that includes an activevalve having an inflatable balloon or other member that actively opensthe valve. It should be understood that the tubes could be formed asmany different types of nasogastric/osogastric (Ng/Og) tubes dependingon the design requirements of those skilled in the art.

The device may include lumens for medication delivery and/or a sump portand sump lumen formed the length of the device body and configured forventing gas and preventing adherence of the device against the gastricwall. In either the passive emesis containment device or the activeemesis containment device, a valve is carried by the device bodymid-esophagus. During an emesis and/or reflux event, the valve openssuch as through the pressure applied by the emesis and/or reflux when apassive valve is used or via a balloon and inflation lumen or othermechanism. Upon expansion of the valve, emesis and/or reflux is blockedfrom passing out of the stomach and past the valve that is positionedmid-esophagus to protect a patient's airway.

In an example, the passive emesis containment device as shown in FIGS.2-18 may be formed as a single or multiple lumen tube. A dense materialmay form the passive valve and a securement may keep the passive valvein a closed position. Pressure such as from emesis and/or reflux mayopen the passive valve. In another example, the passive valve has asecurement that maintains the valve closed. In another example a slidingring is positioned around the valve. A securement could be water solubleor moveable as in the case of the sliding ring. When the tube is placedin the esophagus, the passive valve would be free to open when emesispressure is placed against the passive valve or the ring could slideaway as the device is inserted into the esophagus to allow the valve toopen. The passive valve could be made of multiple density materials withthe closed position as the normal resting state. When opened, thepassive valve is concave towards the stomach for maximum blockingeffectiveness. In an example, the passive valve is formed as a pliablematerial when in contact with the esophageal wall limiting damage to thewall. The passive valve can be capable of multiple opening pressuressuch as between about 2 and 30 psi.

The active emesis containment device is shown in FIGS. 21-27. The activevalve could be a balloon positioned under the flexible sheath andinflated via an automatic device or inflated manually from a cuff orother mechanism with about 2 to about 3 milliliters (ml) of air or otherfluid in one embodiment. The active valve is closed until it isactivated and can also be made of multiple density materials as in thepassive valve such that the closed position is a normal restingposition. The active valve when opened is concave towards the stomachfor maximum blocking effectiveness and formed of a multiple densitymaterial such that a pliable material is in contact with the esophagealwall, limiting damage to the wall.

Any number of passive or active devices with one or more lumens anddifferent sensors and valve openings are possible. It is possible tohave a dual lumen tube with a pressure sensor. In another example, atriple lumen tube has an air pressurized balloon and pressure sensor. Adual lumen tube may include an air pressurized balloon. A quad lumentube may include a pressurized balloon, TDOC air charged pressure sensorand a suction lumen above the balloon. A single lumen tube may include aballoon that opens in the presence of emesis and/or reflux. The distalballoons may be formed to slide up and down passively. The balloons orvalve may be located about 2 to about 3 cm below the aortic notch.Different Ng/Og devices may have radio-opaque markers at the ballooncuff and along the length of the catheter. It is also possible to have adual lumen tube with passive valve and pressure sensor or triple lumentube with an active valve and pressure sensor. Another example is a quadlumen tube with suction above the valve or multiple sensors incombination. The valves are placed about 2 to about 3 cm below theaortic notch. Suction ports can be formed as multiple openings in acircumferential pattern. Fill ports may have luer lock fittings.

FIG. 1 is a diagrammatic view of a patient's body 50 and showing theesophagus 52 and stomach 54 of the patient and showing inserted withinthe esophagus the device 56 used to block emesis and/or reflux inaccordance with a non-limiting example. The device is inserted into theesophagus through the mouth and with the valve 58 positioned below theaortic notch 60. The distal end of the tube is insertable through theesophagus and into the stomach as illustrated. FIG. 1 shows the deviceformed as a nasogastric (Ng) device, but the device could be formed anasogastric/orogastric (Ng/Og) device and inserted through the mouth ornores. The device could be formed as a single, double, triple or quad orother multiple lumen tube. Depending on design, the device preferablycarries at least one sensor that such as a pressure sensor at the distalend communicates to a processing device 62 either through a connectingwire or a wireless connection such as Bluetooth or other RF connection.The proximal end 63 of the tube could include a wired connection totransmit data signals from any device sensors to the processing device62 or a transmitter module 64 for wireless communication of data signalsfrom any device sensors as illustrated. FIG. 1 is illustrated to showthe relative position of the valve about 2 or about 3 centimeters (cm)below the aortic notch. The valves can be passive or active and coulduse a balloon in the case of an active valve. Reference is made to theincorporated by reference '257, '281 and '316 applications disclosedabove that discuss valve placement positions and mechanisms that can beused in conjunction with Ng/Og devices.

FIG. 2 is a fragmentary plan view of a single lumen passive device 100formed as a tube 101 that shows a luer lock 102 at the proximal end 104and a distal end 106 and a passive valve 108 carried by the tube andcomprising a flexible sheath having an upper edge 110 (FIG. 6) securedonto the tube 101. The upper edge is preferably circumferential inconfiguration as illustrated and secured to the tube along its entireedge. An unsecured lower circumferential edge 112 is configured suchthat upon contact of the sheath 109 with emesis and/or reflux from thestomach, the flexible sheath opens in a concave configuration as shownin FIGS. 5 and 6 towards the stomach. When the valve 108 is open, thelower circumferential edge 112 engages the esophageal wall and blocksemesis and/or reflux from the stomach passing into the esophagus andpast the valve 108 as shown in FIG. 1. A suction opening 114 ispositioned at the distal end and received within the patient's stomachas illustrated in FIG. 1. The tube 101 may define a single lumen 115(FIG. 6) or as sump lumen that extends the length of the tube and thesuction opening may define a sump port at the distal end of the tube andconfigured to vent gas. The suction opening could be at the very distalend of the tube.

As shown in FIG. 1, the valve 108 is positioned on the tube to bepositioned mid-esophagus about 2 to about 3 cm below the aortic notch. Aradio-opaque marker 116 is positioned on the valve 108 or adjacentthereto to aid a clinician or physician to position the valvemid-esophagus about two or about three centimeters (cm) below the aorticnotch. For example, a clinician or physician may observe the travel ofthe valve 108 using its radio-opaque marker 116 as it descends theesophagus so that it can be positioned below the aortic notch.

FIG. 4 shows a securement 118 such as a ring that engages and securesthe flexible sheath in its closed or confined configuration shown inFIGS. 2 and 4. In one example, upon insertion of the tube within thepatient's esophagus, this ring or securement 118 is released to allowthe valve to open. In the case of a ring as shown in FIG. 4, emesis fromthe stomach may exert pressure onto the ring and slide it upward to openthe valve as shown in FIG. 6. The securement could also be formed of awater soluble material similar to a band around the closed valve asshown in FIG. 4 at 118 a. This water soluble band 118 a is dissolvedwhen the valve enters the esophagus to allow the flexible sheath to openfreely when emesis presses upward. In each example, the sheath openfreely when esophageal pressure is exerted against the valve and itopens in a concave formation. It can be configured to open when apredetermined pressure of emesis and/or reflux extends upward from thestomach. In an example, the amount of emesis and/or reflux pressure thatopens the passive valve varies, but in a non-limiting example, the valveis formed to open from about 2 psi to about 30 psi. The passive valvecan be designed to open at selected pressures depending on the designconfiguration, the type of material forming the valve, and the amount ofesophageal pressure exerted against the valve. The passive valve can bedesigned to open at a preselected pressure or range of pressuredepending upon the sex, age, general health or medical conditions orother details of the patient. In one example, the flexible sheath 109 isformed from a multiple density flexible material with the closedposition of the valve as a normal state and the material forming anunsecured lower circumferential edge 112 formed to minimize damage tothe esophageal wall as it makes contact therewith.

FIG. 1 also illustrates a system for diagnosing a physiologicalabnormality in a patient. The valve is free to open in a concaveconfiguration towards the stomach as shown in FIG. 1 and the unsecuredlower circumferential edge 112 will engage the esophageal wall and blockemesis and/or reflux from the stomach passing into the esophagus pastthe valve to protect the patient's airway if any emesis and/or refluxoccurs into the esophagus during an involuntary reflex cough event.Greater details of the involuntary reflex cough test as an event and itsphysiology are explained in the incorporated by reference '257, '281 and'316 applications.

As shown in FIG. 1, the processing device 62 is connected in the examplewirelessly through the transmitter module 64 at the device proximal end63 to at least one sensor and configured to process the sensedphysiological condition that occurs during the involuntary reflex coughevent and process that data and determine a physiological abnormality. Asensor in one example could include a first pressure sensor 130 at thedistal end of the tube that is received with the patient's stomach. Asecond pressure sensor 132 and third pressure sensor 134 are positionedabove and/or below the aortic notch 60 or above and/or below the valve58. A pH sensor 136 is included as illustrated. A pH sensor 136 may belocated at a selected area along the tube as explained in the variousincorporated by reference patents. Multiple pH sensors may also be used.An electromyogram (EMG) pad 138 is configured to obtain an EMG frominvoluntary cough activated paraspinal muscles. The processing device isconfigured to receive the IAP and EMG and correlate the TAP and EMG withthe involuntary reflex cough event and determine a physiologicalabnormality. In another example, the processing device 62 correlatespressure from the second pressure sensor 132 with the IAP and EMG. Theprocessing device also may correlate pH measurements from the pH sensor136 with the IAP and EMG. Multiple pH sensors may be positioned alongthe tube and data from each sensor corrected. Further details of theinvoluntary reflex cough event and data processing are set forth in theincorporated by reference '257, '281 and '316 applications.

In one example, the processing device 62 is formed as a portablehandheld device as shown and explained in greater detail in the '257,'281 and '316 applications and includes a housing 62 a at least oneinterface 62 b to receive measurements from at least one sensor such asa pressure sensor and/or EMG pad obtained during the involuntary reflexcough event. A processor 62 c is carried by the housing and operativewith a communications module 62 d and configured to receive through theinterface 62 b the data measurements from different sensors obtainedduring the involuntary reflex cough event. In a system shown in FIG. 1,a nebulized medication is administered to the patient to activate theinvoluntary reflex cough event. This nebulized medication could beadministered such as through a nebulizer lumen formed in the device orusing a standard nebulizer.

FIGS. 7-9 show a dual lumen device 150 that includes the first luer lock102 for a first lumen 115 and a second luer lock 152 for a second lumen153, the valve 108 and a balloon 154 on the distal end that couldoperate as a sensor or a placement device. In the example of FIGS. 8 and9, a first lumen is provided for suction 156 and a second lumen for asensor 158 as shown in FIG. 9. The balloon 154 in FIG. 7 could operate asensor or be used for positioning, securement or other physiologicalmechanisms. As described below, different embodiments could be used.

FIGS. 10-15 show a triple lumen passive device 180 with a third luerlock 182 and a balloon 154 as in FIG. 7. FIG. 10 shows relativedimensions of various components and illustrates how the valve 108 couldbe made from different density materials. It should be understood thatthe material description and described dimensions may apply to any ofthe devices whether passive or active as shown in all the figures. Forexample, material A as shown in FIG. 11 corresponds to the portion ofthe sheath material that engages the esophagus when the valve is openedand could be formed from a material such as “nylon 12” and be about 0.02inches thick in a non-limiting example. Material 13 for the tubematerial shown in the example of FIG. 10 could be formed from PET(polyethylene terephthalate). It should be understood that other similarmaterials could be used as selected by those skilled in the art. FIG. 11is an enlarged view of the passive valve shown in FIG. 10 and FIG. 12 isan enlarged view of the balloon shown in FIG. 10. The sectional viewtaken along line 13-13 in FIG. 11 shows the flexible sheath 109 and acentral or first lumen 115 for suction or a sump lumen and a secondlumen 153 and third lumen 184 that are smaller in diameter and used fora variety of purposes, for example, two sensors, a sensor and balloon orother function. The sectional view taken along line 15-15 of FIG. 11shows the larger first lumen 115 and second lumen 153 such as for asensor and third lumen 184 for a balloon, for example.

Representative non-limiting examples of the device are now set forthwith reference to FIGS. 10-15, but as noted before, can apply to otherfigures. Referring to FIG. 10, dimension A is 20 inches in anon-limiting example and dimension B is 54.6 inches. Dimension C is 30inches and dimension D is 20 inches for each luer lock tube in thisparticular example. Dimension E is 2.54 inches and dimension F is 0.246inches. These dimensions are non-limiting examples and can varydepending on design requirements for a device as required by thoseskilled in the art. In FIG. 11, dimension G is 0.666 inches in anon-limiting example. In FIG. 12, dimension H is 1.334 inches and theradius for dimension I in a non-limiting example is 0.318 inches.Referring now to FIG. 13, an example dimension J is 0.050 inches and anexample dimension for the radius K is 0.015 inches. As shown in FIG. 14as a non-limiting example, dimension L is 0.050 inches and dimension Mis a radius of 0.015 inches. Dimension N in FIG. 15 is about 0.243inches and shows a folded inward edge secured on the tube to impartstrength to the valve and inhibit upward movement of emesis.

FIGS. 16-18 show a quad lumen device 200 with a fourth luer lock 202 andfourth lumen where FIG. 17 is an enlarged plan view of the passive valve108 and showing an upper suction hole 210 that connects to the fourthlumen and allows upper secretions in the esophagus that are above thevalve to be sucked into a fourth or other lumen and out of the device.In this example the device includes a distal balloon 154 as shown inFIG. 18 similar to previous embodiment distal balloons. This particularembodiment shown in FIGS. 16-18 could include a pressure sensor as partof the distal balloon 154 and/or suction below the valve and/or suctionabove the valve. Stomach suction may occur through the standard first ormain lumen in this example as a sump port in another example.

FIGS. 19 and 20 shows an embodiment of an active device 300 as a duallumen active device with the first lumen 302 for suction and the secondlumen 304 used as an inflation lumen (FIG. 20). The valve is formed asan active valve 306 and is carried by the tube 308 and includes aflexible sheath 310 having its upper circumferential edge 312 secured tothe tube and an unsecured lower circumferential edge 314 as in otherexamples. An inflatable balloon 320 is carried by the tube 308 under theflexible sheath 310 and in communication with the inflation lumen 304through a lumen side opening 322. Upon inflation of the balloon, theflexible sheath 306 opens in a concave configuration towards the stomachas in previous examples described above and the unsecured lowercircumferential edge 314 engages the esophageal wall and blocks emesisand/or reflux from the stomach passing into the esophagus past thevalve. The flexible sheath is formed to close when the balloon isdeflated. This active device also includes a radio-opaque marker 330carried by the valve similar to that shown in previous embodiments toaid in positioning the valve mid-esophagus and preferably about 2 toabout 3 cm below the aortic notch when the tube is received through theesophagus. As in previous examples, a sump lumen as the first centrallumen 302 may extend the length of the tube and a sump port at thedistal end of the tube communicates with the sump lumen and isconfigured to vent gas. The flexible sheath 306 in this example also maybe formed from a multiple density flexible material with the closedposition as a normal state when the balloon is deflated and the materialforming the unsecured lower circumferential edge is formed to minimizedamage to the esophageal wall as it makes contact therewith. Typically,after insertion the balloon may be inflated. The sheath could be formedto open in a concave formation such as when a predetermined pressure ofemesis and/or reflux from the stomach is sensed and triggers air to bepumped into the inflation lumen and inflate the balloon to expand thesheath. The lumen 302, 304 could connect to first and second luer locks340, 342.

Pressure could be sensed by a balloon 350 such as shown in FIGS. 21-23that would measure pressure and in some instances be indicative ofemesis and/or reflux and in these examples, the device can be used todiagnose a physiological abnormality by the involuntary reflex coughevent. The third luer lock 344 is illustrated as connected to a thirdlumen.

FIGS. 24-27 illustrate another embodiment of an active device 400 havingan active valve 402 in which the balloon 403 is formed as part of theflexible sheath 404 and includes the upper edge 406 secured on the tube408 and a lower peripheral portion is folded back and an edge 410 issecured on the tube to form the balloon. The inflation lumen receivescompressed air to expand outward the sheath and form the valve. Theinflatable balloon is formed by the sheath itself in this non-limitingexample. The inflation lumen is shown in the sectional view of FIG. 27.Although only one luer lock 442 is illustrated, multiple luer lockscould be connected to any second and third lumens. Two lumens are shownin the sectional view of FIG. 26 with the central lumen 430 operativeand functionally similar to the central lumens in the other embodiment.

FIGS. 28 and 29 show an example of a six-channel system for a processingdevice such as the portable handheld device 62 shown in FIG. 1 andincluding a schematic circuit diagram in FIG. 29 and high-level blockdiagram in FIG. 28. Although a six-channel system is shown, it should beunderstood that a fewer number or greater number of channels can be useddepending on the number of sensors and other inputs desired. A portablehandheld device and has the processing capability to process numerousinputs besides those shown in FIG. 28 or in the specific device examplesof FIGS. 1-27. Data can be transferred with various flow sequences, forexample, as explained in FIGS. 26-26 and 27-28 in the incorporated byreference '257, '281 and '316 applications.

FIG. 28 is a high-level block diagram of basic components for thehandheld device such as shown in FIG. 1 illustrated generally in thisexample at 1200, which in one non-limiting example, uses wirelesstechnology to receive pressure readings such described in theincorporated by reference '257, '281 and '316 applications. This examplerelative to FIG. 28 shows a wired connection. In this example for thehandheld device 1200, the device includes multiple pressure inputs, forexample, to receive Viking connector receptacles and connect to TDOCpressure sensors. As illustrated, the inputs at pressure 1 and pressure2 correspond to the two respective catheters as inputs through thepressure sensors PS1 and PS2 into a pressure converter circuit 1202,which transmits the pressure signals to the onboard processor 1204through various AD signal lines as indicated. The pressure convertercircuit 1202 includes pressure measurement electronics such as shown inthe schematic circuit diagram of FIG. 29 and described in greater detailbelow. The pressure measurements obtained through the pressure sensorsPS1 and PS2 are converted and forwarded to the processor 1204, which inone non-limiting example, is a single board computer such as a RabbitLP3500. The pressure sensors PS1 and PS2 are in one non-limiting exampleTDOC-4030 pressure sensors. The catheters used at inputs P1 and P2correspond in one non-limiting example to TDOC-6F catheters. It shouldbe understood that EMC signals are input through interface circuit 1206into the processor 1204. Data that is processed is displayed using adisplay unit 1208 such a display/keyboard/LED, for example a rabbit KDU.

In one non-limiting example, the pressure converter circuit 1202 ispowered by two nine-volt batteries or in an alternative embodiment byfour AA batteries 1210. The batteries are connected to an on/off switch1212. A programming connector 1214 and RS232 connector 1216 areconnected into the processor 1204 to allow programming of the processorwith appropriate software and code as described before and forprocessing data related to the involuntary reflex cough test. Data canbe retrieved or input. This device 1200 accomplishes both SUI andneuroanalysis using the appropriate data analysis.

FIG. 29 is a top plan view of the housing 1220 for the handheld deviceand showing a location for a power on/off toggle switch 1234 and adisplay with a keyboard and light emitting diodes (LED's) 1236.Non-limiting examples for possible dimensions for the handheld deviceare about 8 inches (x) and 5 inches (y).

FIG. 29 is a schematic circuit diagram of the pressure converter 1252 inaccordance with a non-limiting example and showing the various pressuresensor 1 input 1240 and pressure sensor 2 input 1242. These areindependent channels each with comparators and operational amplifiersillustrated generally at 1244 and 1246 respectively. These componentsand circuits connect into appropriate pin headers 1248 and 1250 thatoutput to a single board computer in this non-limiting example.

Different processors 1204 as a single board computer can be used in anon-limiting example. The described Rabbit microprocessor is alow-power, single-board computer and is especially operable withportable handheld, battery-powered, remote monitoring systems. Itincludes built-in analog and digital input/output and typically consumesless than 20 milliamperes when operational and less than 100 microampsin a power-save mode. In this non-limiting example, it includes flashmemory and SRAM and various inputs/outputs and in one non-limitingexample eight analog/digital converter inputs with programmable gain andsix serial ports. It has pulse width modulation (PWM) outputs. It can beprogrammed using C software in a non-limiting example.

It should be understood that the display unit 1208 as illustrated inFIG. 28 is a separate display unit that includes the display, keyboardand light emitting diodes and supported on the housing, but could beincorporated integral with the single board computer in a non-limitingexample.

FIGS. 28 and 29 show a representative six channel system in which threepH inputs are illustrated, for example, for measuring pH, for example,when pH probes or sensors are situated on a device such as shown in FIG.1 and pH probes or sensors are located in the stomach, at the loweresophageal sphincter (LES), mid-esophageal area, and/or superioresophageal area as a non-limiting example. It should be understood thatan eight channel system can also be used in which there may be four pHchannels for the four locations as described, two pressure channels andtwo EMG channels. One of the channels, in the alternative, could be aspare channel. Ten or more channels could be used. Multiple EMG orpressure inputs could be used. The particular choice by channels is achoice of one skilled in the art based on the type of Ng/Og device thatis used and what is being analyzed.

In an example, the EMG sensor circuit could incorporate a DELSYS DE-2.1and the pH measurement probe could incorporate a MediPlus 25100 asnon-limiting examples. The pressure sensor could be a TDOC-4030 for PS1and PS2 and the catheter function as P1 and P2 could be a TDOC-7F.

There now follows an example of a pseudocode, which explains in a morecogent manner the function of the programming code that could be usedwith the handheld device as described in accordance with a non-limitingexample:

/******************************************************************************Function : Init_Arrays Description : Initializes all the arrays topredefined values deemed as having no valid meaning.******************************************************************************/Init_Arrays( ) While (index <NUM_ENTRIES)  VesicularPressure[index]=UNDEF_PRESSURE AbdominalPressure [index]= UNDEF_PRESSUREDetrusorPressure [index] = UNDEF_PRESSURE index = index + 1 End WhileEnd // Init_Arrays/******************************************************************************Function : Calculate_Pdet_Array Description : Calculates theDetrusorPressure values throughout the cough event and populates thearray accordingly.******************************************************************************/Calculate_Pdet_Array( ) index = CoughStart While (index <=CoughStop)DetrusorPressure [index]= VesicularPressure [index] − AbdominalPressure[index] index = index + 1 End While End // Calculate_Pdet_Array/******************************************************************************Function : Normalize_Event_Array Description : Normalizes the Pves forthe duration of the cough event only, by subtracting the baselinepressure from every Pves value.******************************************************************************/Normalize_Event_Array( ) index = CoughStart While (index <=CoughStop)VesicularPressure [index]= VesicularPressure [index] − BaseLinePressureindex = index + 1 End while End // Normalize_Event_Array/******************************************************************************Function : Average_Pressure Description : Calculates the average valueof an array subset.******************************************************************************/Average_Pressure( ) Sum = 0; index = CoughStart While (index<=CoughStop) Sum = Sum + VesicularPressure [index] index = index + 1 EndWhile AveragePressure = Sum/( CoughStop − CoughStart + 1) End //Average_Pressure/******************************************************************************Function : Peak_Pressure Description : Finds the peak value of an arraysubset.******************************************************************************/Peak_Pressure( ) PeakPressure = UNDEF_PRESSURE index = CoughStart While(index <=CoughStop) If (VesicularPressure [index]>= PeakPressure)PeakPressure = VesicularPressure [index] End If index = index + 1 EndWhile End // Peak_Pressure/******************************************************************************Function : Find_Level_Pressure Description : Searches a subset of thepressure array for a window where the pressure is “relatively” level.******************************************************************************/Find_Level_Pressure( ) index = 0 While (index < NUM_ENTRIES) CalculateSlope between VesicularPressure [index] and VesicularPressure [index+1]If (Slope < SlopeTolerance) If (Duration > XTime) ) Stop = index−1Escape While End If End if index = index + 1 End While End //Find_Level_Pressure/******************************************************************************Function : Event_Start Description : Determines the start point for acough event by examining the slope between consecutive points.******************************************************************************/Event_Start( ) index = 0  While (index < NUM_ENTRIES) Calculate Slopebetween VesicularPressure [index] and VesicularPressure [index+1] If(Slope > SlopeTolerance) If (Count > ConsecutiveTimes) Start = indexEscape While End If Count = Count + 1 End if index = index + 1  EndWhile End // Event_Start/******************************************************************************Function : Event_End Description : Determines the end point for a coughevent by examining the slope and determining if the pressure hasremained relatively unchanged for a certain length of time.******************************************************************************/Event_End( ) Stop = Find_Level_Pressure( ) End // Event_End/******************************************************************************Function : Boundarize_Event Description : Determines the start and endpoints for a cough event.******************************************************************************/Boundarize_Event( ) CoughStart = Event_Start( ) CoughStop = Event_End( )End // Boundarize_Event/******************************************************************************Function : Baseline_Pressure Description : Determines the baselinepressure for a cough event by looking for a relatively flat pressure forat least a 2 second window prior to the cough event.******************************************************************************/Baseline_Pressure( ) Start = 0; Average = Average_Pressure( ) Stop =Find_Level_Pressure(Average) If (Stop > (Start + 2 seconds)) Start =Stop − 2 seconds End If BaseLinePressure = Average_Pressure (Start,Stop)End // Baseline_Pressure/******************************************************************************Function : Calibrate Description : Allow the user to calibrate thepressure sensors. If voltage levels are too low the program will exit.******************************************************************************/Calibrate( ) Voltage = ReadAnalogVolts( ) If (Voltage < 14.0)Display(“Please replace 9V batteries!”) Exit Program Else If (Voltage >=14.0) Voltage = ReadAnalogVolts( ) If (Voltage < 6.0) { Display(“Pleasereplace AA batteries!”) Exit Program End If Display {“Connect pressuresensors and place in OPEN position.”) Vp1cal = ReadAnalogDiff(Channel0)Vp2cal = ReadAnalogDiff (Channel2) Display (“Unit calibrated. Close bothpressure sensors.”) End If End // Calibrate/******************************************************************************Function : In_Patient_Physiology Description : Performs the inpatientphysiology algorithm.******************************************************************************/In_Patient_Physiology(void) If (PostVoidResidual > 100.00) If(RestingDetrusorPressure > 15.00) dispLedOut(RED) // UMN Bladder //Detrusor/sphincter dyssynergia (DSD) // UROLOGY EVAL Else If(RestingDetrusorPressure <= 15.00) If (MaxVoidingDetrusorPressure >60.00) If (PatientLeaked) dispLedOut(YELLOW) // Bladder OutletObstruction (BOO) // Overflow incontinence // Possible DSD ElsedispLedOut (YELLOW) // Bladder Outlet Obstruction (BOO) // Possible DSDEnd If Else If (MaxVoidingDetrusorPressure <= 60.00) If (PatientLeaked)dispLedOut(YELLOW) // Overflow incontinence // Possible SUI ElsedispLedOut(YELLOW) // Atonic bladder // Hypotonic bladder End If End IfEnd If Else If (PostVoidResidual <= 100.00) If(RestingDetrusorPressure > 15.00) dispLedOut(YELLOW) // Detrusorinstability // Urge incontinence // Mixed incontinence Else If(RestingDetrusorPressure <= 15.00) If (PatientLeaked) dispLedOut(YELLOW)// SUI Else dispLedOut(GREEN) // Normal Study End If End If End If End// In_Patient_Physiology/******************************************************************************Function : Run_RCT_Test Description : Performs the steps to run the RCTtest.******************************************************************************/Run_RCT_Test( ) RestingBladderVolume = SetBladderVolume(“Please scan andenter RBV: ”) Display (“Please place the catheter) Display (“Pleaseplace the pad”) Start measuring to establish baseline andDetrusorPressure Calculate Resting DetrusorPressure for 30 secondsDisplay (“Please perform iRCT test) PostVoidResidual =SetBladderVolume(“Please scan and enter PVR: ”) PatientLeaked =VerifyLeak(“Did patient leak (Y/N)?”) Stop measuring pressuresBaseline_Pressure( ) Boundarize_Event( ) PeakPressure = Peak_Pressure( )Average = Average_Pressure( ) Calculate AreaUnderCurveIn_Patient_Physiology( ) Display ( PeakPressure , Average,AreaUnderCurve) End // Run_RCT_Test//------------------------------------------------------------------------// Main program runs the display with menu.//------------------------------------------------------------------------main ( ) Initialize all hardware and parameters Init_Arrays( ); while(Not Exit)  Get MenuOption from the user If (MenuOption = 1) Calibrate() Else If (MenuOption = 2) Run_RCT_Test( ) Else If (MenuOption = 3) Download measured and calculated data Else If (MenuOption = 4) ExitProgram End If End While End // main

FIGS. 30A-30E show a modified device such as that illustrated in theincorporated by reference '257, '281 and '316 applications, but modifiedto include an active valve as explained relative to FIGS. 19-23 andFIGS. 24-27. A balloon is illustrated in these examples. FIGS. 31A-31Fshow a passive valve used on the device as in the incorporated byreference applications.

The device may include a pressure “bubble” at the end of the inflationlumen and could include a manometer connected for measuring pressure,for example, at the valve and against the esophageal wall. Another lumenextending through the main body could be included with holes for suctionjust above the Lower Esophageal Sphincter (LES) to aid in suctioningreflux or emesis. This is advantageous for a surgery patient or acuteneural or trauma patient. Details of such device are explained below.

It should be understood that stroke can cause Lower Esophageal Sphincter(LES) weakness. The LES is weakened by stroke and other factors,including the initiation of an involuntary cough such as through theiRCT test. The Ng/Og device, in accordance with a non-limiting exampleand described in detail below, acts as an esophageal reflux protectiondevice to protect the patient from the weakness of the Lower EsophagealSphincter (LES). It is known that cough causes reflux, which causes morecough. This is a vicious cycle. This device allows blocking of emesisand prevents reflux associated with pneumonia and anesthesia or otherfunctions affecting neural patients. The Ng/Og device shown in FIGS.30A-30F can be used when there is microscopic reflux or massive emesis,which both can cause pneumonia.

It should be understood that the esophagus is about 25 centimeters long.It is a muscular tube with a diameter of about 2 centimeters average. Ittracks the vertebral column curve and descends through the neck andposterior medistinum and passes through the esophageal hiatus in theright crus of the diaphragm to the left of the median plane at the levelof the T10 vertebrae.

The esophagus enters the stomach at the cardial orifice to the left ofthe midline at the level of the 7th left costal cartilage and T11vertebra. The abdominal part of the esophagus extends from theesophageal hiatusis in the right crus of the diaphragm to the cardial(cardiac) orifice of the stomach. This area is only about 1.25 cm long.

Food passes through the esophagus rapidly because of the peristalticaction and is typically not dependent on gravity. The esophagus isattached to the margins of the esophageal hiatus in the diaphragm by thephrenicoesophageal ligament, an extension of the inferior diaphragmaticfascia. This ligament permits independent movement of the diaphragm andesophagus during respiration and swallowing. The esophagogastricjunction lies to the left of the T11 vertebra on the horizontal planethat passes through the tip of the xiphoid process. Immediately superiorto the esophagogastric junction, the diaphragmatic musculature formingthe esophageal hiatus functions as a physiological inferior (lower)esophageal sphincter (LES) that contracts and relaxes. The sphinctermechanism for the LES is typically efficient in preventing reflux ofgastric contents into the esophagus based on radiological studies. Thelumen of the esophagus is normally collapsed superior to this level toprevent food or stomach juices from regurgitating into the esophaguswhen an individual is not eating.

Barium fluoroscopic studies of the esophagus normally show threeconstrictions of the esophageal lumen due to impressions from adjacentstructures. These are possible locations for placing a device for refluxanalysis and GERD treatment.

A first constriction is the cervical constriction (upper esophagealsphincter). The superior aspect of the esophagus is thepharyngoesophageal junction, and is approximately 15 cm from the incisorteeth. The cricopharyngeus muscle creates this cervical constriction,which is located at approximately the level of the sixth cervicalvertebra.

A second constriction is the thoracic (broncho-aortic) constriction. Thearch of the aorta and the left main bronchus cross the esophagus andcreate esophageal constrictions as seen on anteroposterior and lateralviews, respectively. The constriction caused by the arch of the aorta is22.5 cm from the incisor teeth and the constriction formed by the leftmain bronchus is 27.5 cm from the incisor teeth.

A third constriction is the diaphragmatic constriction. The esophagealhiatus of the diaphragm is approximately 40 cm from the incisor teethand forms the diaphragmatic constriction. This is at the level of thelower esophageal sphincter.

The presence of these constrictions is important when placing the deviceand its active or passive valve, which would help prevent the reflux ofgastric contents into the upper esophagus and pharynx. The placement ofthe device and valve in one example is suggested inferior to thebroncho-aortic constriction (27.5 cm from the incisor teeth), butsuperior to the diaphragmatic constriction at 40 cm from the incisorteeth. The device typically should not be placed in regions of theesophagus with pathological involvement of the esophagus.

FIGS. 30A-30E show the device in plan and sectional views and indicatedgenerally at 1400, and includes a main device body 1401 and the activevalve with a separate inflation lumen 1404 for inflation and deflationof the balloon 1402 positioned under the flexible sheath 1403 as shownin FIGS. 30B-30D. FIG. 30D shows the balloon 1402 in dashed lines andinflated. Air channels 1405 connect the inflation lumen and the balloonas shown in FIG. 30 d. The section view in FIG. 30 e shows thetermination of the inflation lumen.

The tip of the device is shown positioned in the stomach, which is shownschematically in FIG. 30 a. FIG. 30 c is a cross-section taken alongline 30 c-30 c of FIG. 30 a. FIG. 30 d is a cross-section taken alongline 30 d-30 d of FIG. 30 a. FIG. 30 e is a cross-section taken alongline 30 e-30 e of FIG. 30 a. In these cross-sections, the various lumensare shown, including the main lumen 1406, the sump lumen 1408, theinflation lumen 1404 used for inflating the balloon, and any suctionlumens 1410 that are used for suction above the LES. The sump lumen 1408is connected to a sump port 1412 (FIG. 30 a) at the end of the device1400. Drainage holes 1414 positioned in this example above the valve1402 allow secretions to pass into the device. These drainage holescould be formed as suction holes and connected to any suction lumens.Suction holes 1416 are positioned below the valve 1402 and connect tothe suction lumens 1410 to permit emesis and reflux to be suctioned. Thedrainage holes could also connect to the suction lumen 1410 as notedbefore. In a non-limiting example, the drainage holes and suction holesinclude one-way valves to allow emesis to enter, but not return.

The device can come in variable sizes and lengths depending on patientneeds and requirements and typically a standard size for use dependingon patients. The device can be used for gastric enteral feedings orgastric decompression resulting from the use of the Salem sump port1412. The device typically includes radio-opaque markings 1420throughout the length of the tube as illustrated for measurement andplacement. Measured markings 1421 as indicia can be positioned in oneexample along the length of the tube together with a color changingmaterial or pit sensitive material and at the bulb/cuff for measuringemesis, etc. One radio-opaque marker on the valve itself is used toplace the valve about 2 to about 3 cm below the aortic notch.

Inflation and deflation of the balloon in this example is through theluer lock port 1404 a for air or fluid entry and exit to form theballoon that includes a pressure balloon 1422 adjacent thereto. Themanual pressure balloon 1422 allows for a tactile cuff and a grosspressure check such as through a manometer 1424 attached thereto. Theluer lock port 1404 a attaches in one example to a manometer for actualcuff pressure measurement. The balloon 1402 easily collapses foremergency removal or self-extubation without causing damage tosurrounding structures of the esophagus, hypopharynx, pharynx, and oralcavity. The balloon can be kept inflated below the capillary pressure ofthe esophageal wall to prevent ischemia that is typically about 7-8centimeters (cm) water. As indicated before, there are radio-opaquemarkings 1420 to aid in valve placement confirmation. Theinflation/deflation port 1404 a can be a different color than theopenings for the sump lumen, the suction lumen and the main lumen. Theinflation/deflation port 1404 a in one example is fitted with thestandard luer lock cap and the inflation/deflation port can be labelledwith the term “esophageal valve” to aid practitioners in identifying theport.

The Ng/Og device is typically inserted through the nasal cavity orthrough the oral cavity and enters into the stomach. Measurements can bemade from the lips or nares to the TMJ (temporomandibular joint) and toabout four-finger breadths to sub-xyphoid. When the balloon is deflated,a water-soluble lubricant can be applied to the end of the device to aidinsertion. This Ng/Og device is inserted in a manner similar to an OgT(orogastric tube) or NgT (nasogastric tube) (Ng/Og tube) with theclinician or nurse using the placement radio-opaque markings 1420 toposition the device over the lungs and stomach and the valve 2 to about3 cm below the aortic notch. Once it is in position, it is possible touse auscultate placement by listening to sounds and using an air bolusinto the tube and attempt to aspirate gastric contents from the tube.The device is secured and its placement confirmed by x-ray (using theradio-opaque markings 1420 for help) and the preferred location of thevalve is inferior to the broncho-aortic constriction while superior tothe diaphragmatic constriction. The balloon 1402 is inflated through theinflation lumen 1404 and the balloon pressure may be measured with themanometer 1424. The main lumen 1406 as part of the device body 1401 willhave low continuous or intermittent suction and may also be used toadminister external feedings.

In accordance with a non-limiting example, the involuntary Reflex CoughTest (iRCT) is used to evaluate the impairment and/or recovery of airwayprotection. An advantageous pressure for the balloon 1402 and thusflexible sheath against the inside wall of the esophagus is below theesophageal wall capillary pressure. The use of the involuntary reflexcough test is advantageous for people who are neurologically impaired tocheck to see if they can protect their airway. In this particular deviceexample, pressure sensing is used in conjunction with the device. EMGdetermination can also be used, as well as pH sensing. Any transceiverinputs for pressure, pH or EMG could input directly into the handhelddevice. For example, the device could carry pressure sensors as pressuretransducers 1430 at various locations on the device to measure pressurewhen the device is inserted within the esophagus. The transducers 1430could have transducer leads 1432 that extend through the sump lumen 1408or be embedded in a wall of the main tube or one of the other lumens.One pressure sensor or transducer 1430 could be in the stomach (such asat the sump lumen), another at the LES, another at mid-esophageal and/oranother at the superior esophageal location. It is possible to use anair charged catheter as a pressure sensor with a separate lumen fordetermining pressure in the stomach, which can be used to determineintra-abdominal pressure. An air charged catheter would require somecalibration. Other sensors as non-limiting examples could use fiberoptic or other circuit means. The intra-abdominal pressure can bemeasured but also intra-thoracic pressure. Reflux can be measured byhaving pH sensors 1434 as inputs along the side with leads alsoextending through the sump lumen in this example. The handheld devicecan connect by wired connection or wireless connection to the variouspressure, pH and EMG sensors, probes, pads, transducers, etc. It shouldalso be understood that the catheter can be coated with a color changingmaterial, such as for indicating the extent of acid reflux or emesis.

The device includes a nebulizer lumen 1450 that is extralumenal to themain device body 1401 and provides a nebulizer function using a separatenebulizer port 1452 from the main lumen. This nebulizer port 1452connects to an oxygen or air source for delivering medication such asfor the involuntary reflex cough test at the esopheryngeal area forinhalation into the pulmonary tree or medicine for treating a patient.As illustrated, the nebulizer lumen 1450 terminates at a nebulizerstructure or nebulizer/medication delivery mechanism having a built-inventuri 1454 to allow delivery of medication for the iRCT around aportion or all the main device body 1401 forming the tube.

FIG. 30 b shows a cross-section taken along line 30 b-30 b and showingthe venturi of the nebulizer and the main lumen 1406,deflation/inflation lumen 1404, suction lumen 1410, and sump lumen 1408.The two suction lumens 1410 may merge near the proximal portion of themain body or be separate and provide either common suction at the sametime above and below the cuff or individually controlled suction. Thesuction holes or ports as noted before include one-way valves to allowfluid into the suction lumen 1410, but not out. The valves could beformed as cut flaps that extend inward, but not outward to allowingress, but not egress. This is advantageous such as when emesisextends upward around the tube from the stomach and can pass into thetube to be suctioned, but not passed back out. Also, secretions, if theyget past the cuff, will be suctioned by the suction ports that arelocated above the cuff as illustrated.

The pressure transducers 1430 are located at various points such as atthe distal tip at the sump to measure intra-abdominal pressure. Apressure transducer 1430 can be located below the cuff 1430 and abovethe cuff 1402 with leads extending through the sump lumen 1408 andconnected to the handheld device. A pressure transducer 1430 in oneexample is located at the sump lumen (FIG. 30 f). As noted before, it isalso possible to include pH sensors 1434 on the device that includeleads extending through the sump lumen 1408, allowing pH to be measuredto detect when emesis is rising from the stomach. The pH sensors 1434could be located at different locations such as below the cuff and abovethe cuff and even farther up along the main device body 1401. Thecoating on the device could indicate pH.

This Ng/Og device as illustrated in FIGS. 30A-30F is a multi-purposeNg/Og device that can be used in a variety of patients who are at riskfor aspiration of gastric contents, elevated intra-abdominal and/orintra-esophageal pressures, and/or abnormal airway protection. Thedevice is not limited to the illustrated embodiments, but can beconfigured with all or any variation in combination of differentcomponents to fit the needs of the patient.

An esophageal suction port 1416, which in this embodiment is below thevalve, but could also be positioned above the valve together with orbelow the valve, permits suction to occur and uses one-way port holesthat are located above and below the esophageal cuff such that emesis,reflux and other material can be sucked into the suction lumen 1410 butnot pass out. Any suction ports 1416 open with the administration of lowpressure and intermittent suction. Low suction can be applied to removethe refluxed gastric material in the lower esophagus below the valve.The low suction can also be applied to remove material such as, but notlimited to, oral or nasal secretions, medications and/or tube feedingmaterial that is collected in the esophagus above the esophageal cuff.For purposes of identification to the nurse or other practitioner, itcan be labelled as “Intra-Esophageal Access: Do Not Instill.”

The nebulizer venturi 1454 will typically be positioned at the level ofthe larynx between the nasal pharyngeal area/oral pharyngeal area andallow medication to be administered. The device can be used to measureboth intra-abdominal hypertension and reflux. The dimensions of thisdevice are not larger than a regular Ng/Og tube and not larger than 18to about 20 French in one example. The sump lumen is much smaller ascompared to the main tube, but in this example, large enough toaccommodate various leads, which could extend through other lumens. Thesump lumen, however, typically remains more clean.

The device is also a fully functioning feeding tube for food, liquids ormedicine to the stomach and acts as a separate reverse channel, to allowsuctioning below the LES in the stomach, and the possibility forconstant low-pressure suctioning for reflux above the LES. In apreferred example, the device collapses with pulling even if it is notdeflated and pulled by a patient for safety. As noted before, xrays canbe used to aid placement of the device in the esophagus by viewing theradio-opaque marker on the valve. This device can be engineered asnecessary for any severe neuro functions and risks for LES weakness orincreased LER activity because of dysphagia or reflux, and protectgeneral anesthesia patients after extubation. The device is useful foriRCT testing and protects the patient from neutral created anti-acidmedicine stomach content reflux that might get past the ASIC receptorsor RAR's (retinoic acid receptors).

The device as described has many different advantageous uses. The topportion of the device includes different ports and non-ports, alloperating together as an Ng/Og tube for oral or nasal uses. This devicealso can test reflex cough and deliver micro-nebulized medicines, suchas disclosed in the commonly assigned U.S. patent application identifiedalso.

In the past, Ng/Og tubes were not used with a patient that could notprotect their airway. This protective NG/OG device as described,however, in accordance with a non-limiting example, is safely used witha patient that cannot protect their airway and especially useful whenadministering the iRCT in case reflex occurs. The device can be left ina patient for protection.

FIGS. 31A-31E show a device similar to that shown in FIGS. 30A-30Fexcept a passive valve is used and there is no balloon and no need foran inflation lumen and none are illustrated as shown in the variouscross-section views. The same description applies except balloonpressure concerns are not necessary. There is also no requirement forthe manual pressure balloon and manometer, and none are illustrated.

For purposes of technical understanding, some description of theinvoluntary reflex cough test is set forth.

The induced reflex cough test (iRCT) activates the nucleus tractussolitarius (NTS), as compared to the voluntary reflex cough test. TheiRCT selectively activates neurons in or adjacent to the NTS. The NTSconveys impulses to brainstem and spinal cord motor nuclei thatstimulate muscles involved in expiration (expiration) associated withthe laryngeal expiratory reflex (LER), i.e., involuntary cough. In thebrainstem the NTS conveys impulses to the nucleus ambiguous, whichcontrols opening and closing of the glottis of the larynx. In the spinalcord, descending impulses from the NTS will stimulate neurons in oradjacent to the Medial Motor Cell Column (MMCC). The MMCC will controlparaspinal muscles, expiratory muscle of the trunk, e.g., externalabdominal oblique muscles, and pelvic floor musculature. The LER motorpattern elicited by the iRCT is a bilaterally symmetrical andsynchronized motor event. In the past, urologists did not selectivelyactivate MMCC without overtly activating spinal neurons of the lateralmotor cell column (LMCC), which are associated with limb musculature.Magnetic stimulation or electrical spinal cord stimulation activatesboth MMCC and LMCC and thus it is not possible to sort out pathologywith these tests. Magnetic stimulation or other approaches from CNSactivation also activate both columns.

The induced reflex cough test (iRCT) activates the LER, which isessential for clearing the upper airway of potential aspirants duringeating or inhalation. The LER elicits contraction of the abdominalmuscles, which compresses the abdominal structures and thereby increasesintra-abdominal pressure (IAP) and displaces the diaphragm superiorly.During this natural abdominal compression, the upward displacement ofthe diaphragm will generate the cough force necessary to clear the upperairway and also increase the pressure inside the urinary bladder(intravesicular pressure). During this motor event involving an increasein IAP, all intrinsic sphincters of the abdomen (e.g., lower esophagealsphincter (LES)) and pelvis urethral and anal sphincters must bephysiologically closed. If these sphincters are not closed during a LERinvoluntary cough episode, the individual may have gastro-esophagealreflux (GER) and/or urinary and/or fecal incontinence.

The laryngeal expiratory reflex (LER) is a brainstem-mediated reflexthat initiates an immediate series of expiratory coughs without aninspiratory phase. The LER is the involuntary reflex that neurologicallyprotects the upper airway from noxious aspirants and, as such, it has acritical neurological function, which is unique to humans. The inducedreflex cough test (iRCT) can be triggered such as by using a nebulized20% solution of a mild chemo-irritant to elicit in patients a LER. TheiRCT is characterized by a series of, at least, five expiratory reflexcoughs (C5) with a typical 17 ms latency to the external abdominaloblique (EAO) muscles. During the LER, contraction of the EAO musclescompress the abdominal viscera, which push against the relaxed diaphragmsuperiorly for the expiratory phase and push inferiorly against theurinary bladder and rectum, with a concomitant increase inintra-abdominal pressure (IAP).

Since reflex cough is expiratory and is not preceded by diaphragmaticcontraction associated with inspiration, the iRCT indicates the nativetonicity and function of the urethral sphincter (US) and loweresophageal sphincter (LES), which is typically critical in the diagnosisof SUI and GERD, respectively. Animal models cannot adequately study thevoluntary cough (VC) and the LER, since the animals are surgicallydecerebrated and intubated.

FIG. 32 is another view of the device 500 similar to that shown in FIG.20 with numbers in the 500 series and showing a first lumen 502 as asuction lumen and a second lumen 504 as a vacuum lumen that draws vacuumthrough the lumen side openings 522, which are illustrated as three sideopenings or vacuum ports. In this embodiment shown in FIG. 32, theexpandable esophageal cuff 506 corresponds to the “active valve” of FIG.20 but is a “passive” device since it is normally “open” and passivelyopens when the vacuum draw is terminated. The cuff 506 is carried by thedevice body or tube 508 mid-esophagus and configured in a normallyexpanded position such that when inserted within the esophagus, theesophageal cuff conforms to the interior surface of the esophagus andemesis and/or reflux is blocked from passing out of the stomach past theesophageal cuff. The vacuum lumen 504 is formed within the device bodyand connected to the expandable esophageal cuff through the lumen sideopenings 522. When the vacuum is applied, the esophageal cuff 506 iscontracted against the device body 508 to permit the device to beinserted and placed within the esophagus and when the vacuum isreleased, the esophageal cuff expands against the interior surface ofthe esophagus. In the embodiment shown in FIG. 32, the esophageal cuffincludes a flexible sheath 510 having an upper edge 512 secured onto thedevice body or tube 508. An expandable balloon 520 is secured onto thedevice body under the flexible sheath 510 and attached to the undersideof the flexible sheath. A foam material 528 in one example fills theballoon 520 that is compressed when vacuum is applied through the vacuumports 522 such that the flexible sheath 510 contracts against the devicebody or tube 508 to allow insertion.

Although a foam material 528 is described as contained within theballoon 520, other materials may be used as long as they expand when thevacuum is removed and contract or compress the balloon against thedevice body 508 when vacuum is applied. A foam material is advantageousand may be formed as a spongy cellular material produced, for example,by reacting polyester with diisocyanate. Carbon dioxide may be liberatedby the reaction of a carboxyl with diisocyanate. Polyester resin reactswith a compound while CO2 is simultaneously released by anotherreaction. The gas creates a pocket that, in turn, makes the materialsoft and light, and may be compressed and expand outward when the vacuumis released. The foam is secured against the interior surface of theballoon such that the balloon would expand or contract depending onvacuum draw.

It is also possible to form the balloon 520 to include an outer materialthat is molded in its expanded condition and flexible enough such thatwhen vacuum is drawn, it contracts against the surface of the tube, andthus, forces down the flexible sheath into its contracted position sincethe flexible sheath is secured to the balloon. When the vacuum isreleased, the surface of the balloon expands outward, forcing theflexible sheath open to form the “valve” or cuff that engages theinterior wall of the esophagus to block emesis.

The sheath 510 may be formed of a pliable material such that when incontact with the esophageal wall, it limits damage to the wall. Thisfoam material, in one example, may be designed to open with apredetermined expansion force when vacuum is released, and whencompressed, require vacuum drawn from a slight vacuum or greater amountsof vacuum. As in previous embodiments, the esophageal cuff 506 may beplaced about 2 or 3 centimeters (cm) below the aortic notch as shown inFIG. 1. It is possible to use a water soluble band as in previousembodiments that facilitates insertion of the device. When the banddissolves, the foam in the balloon is allowed to expand outward to movethe flexible sheath into its open position to block emesis. When thetube is to be retracted from the esophagus, vacuum is applied to closeor compress the cuff.

Similar dimensions may apply as in previous embodiments as describedrelative to FIGS. 10-15, for example. The sheath may be formed fromdifferent materials, including a material such as “nylon 12” and beabout 0.02 inches thick in a non-limiting example and include a materialB for the two materials such as shown in the example of FIG. 10, to beformed from PET (polyethylene terephthalate).

The vacuum lumen and a source of vacuum may be incorporated within theNg/Og device as shown in FIG. 35A. Instead of a manometer, a vacuumsuction channel is employed as illustrated. The separate inflation lumenshown in FIGS. 30A-30F instead becomes a vacuum lumen 1404′ shown withprime notation, but the structure of the lumen remains the same in thisexample and the air channels 1405′. Other structural similarities remainthe same in this example of FIGS. 35A-35F. The processing devicedescribed relative to FIGS. 28 and 29 may be used with the Ng/Og deviceshown in FIGS. 35A-35E.

FIG. 33 is another embodiment of the device 602 beginning in the 600series similar to that shown in FIG. 26, but instead showing a foammaterial within the expandable balloon 603 as is formed by the flexiblesheath 604 having its upper and lower edges 610 secured onto the devicebody or tube 608 and forming that expandable balloon 603. Two vacuumside ports or openings 611 are illustrated as connected to the vacuumlumen 620. A foam material 605 fills the expandable balloon 603 and iscompressed when vacuum is applied such that the flexible sheath 604contracts against the device body or tube 608. In this example 2, vacuumside lumen openings 611 are illustrated. This embodiment has theadvantage of not requiring a separate balloon attached underneath theflexible sheath. The flexible sheath 604 in this example may also beformed as a naturally molded flexible material that expands outward, butmay be contracted when vacuum is applied.

FIG. 34 shows another embodiment beginning in the 700 series in which aflexible sheath 704 is secured at its lower and upper ends 706, 710similar to that shown in the embodiment of FIG. 33, but does not includea folded over section as in the embodiment of FIG. 33. Instead thebottom sheath 704 forms a tapered expandable balloon 703. Three vacuumside openings or ports 711 are illustrated to compress the sheathforming the balloon 703 when vacuum is drawn. A foam material 705similar to that used in the embodiment of FIGS. 32 and 33 may be used.The main or first lumen 730 and vacuum lumen 720 are illustrated. Vacuumdrawn through the vacuum lumen 720 compresses the balloon against thedevice body or tube 708.

It should be understood that other types of materials may be used toexpand the balloon when no vacuum is applied. As noted before, theflexible sheath material 704 may be formed of a material that expandsoutward naturally through its fixed molecular structure and may becompressed when vacuum is drawn. Other spring mechanisms such asradially extending springs could possibly be used and positioned withinthe balloon. Foam has been found advantageous because it allows theesophageal cuff to conform to the irregular esophageal surface to blockemesis passively. The foam esophageal cuff passively opens when thevacuum is removed. When vacuum is drawn, the esophageal cuff iscompressed to conform to the Ng/Og device outer surface formed by thetube and inserted within the esophagus when it is deflated or depressedwith the vacuum applied.

Many modifications and other embodiments of the invention will come tothe mind of one skilled in the art having the benefit of the teachingspresented in the foregoing descriptions and the associated drawings.Therefore, it is understood that the invention is not to be limited tothe specific embodiments disclosed, and that modifications andembodiments are intended to be included within the scope of the appendedclaims.

That which is claimed is:
 1. A nasogastric/orogastric (Ng/Og) device,comprising: an elongate device body having a distal end for insertioninto the stomach through the esophagus and a proximal end, and having amain lumen extending the length of the body and configured for at leastone of gastric decompression, enteral feeding and enteral medicationadministration; an expandable esophageal cuff carried by the device bodymid-esophagus and configured in a normally expanded position such thatwhen inserted within the esophagus the esophageal cuff conforms to theinterior surface of the esophagus and emesis and/or reflux is blockedfrom passing out of the stomach and past the esophageal cuff; and avacuum lumen carried by the device body and connected to the expandableesophageal cuff, wherein when vacuum is applied, the esophageal cuff iscontracted against the device body to permit the device to be insertedand placed within the esophagus, and when the vacuum is released, theesophageal cuff expands against the interior surface of the esophagus.2. The device according to claim 1, wherein the expandable esophagealcuff comprises a flexible sheath having an upper edge secured onto thedevice body.
 3. The device according to claim 2, further comprising anexpandable balloon secured on the device body under the flexible sheathand attached thereto, and a foam material in the balloon that iscompressed when vacuum is applied such that the flexible sheathcontracts against the device body.
 4. The device according to claim 2,wherein the flexible sheath comprises a lower edge secured onto thedevice body and forming an expandable balloon, and a foam material inthe balloon that is compressed when vacuum is applied such that theflexible sheath contracts against the device body.
 5. The deviceaccording to claim 1, further comprising at least one pressure sensorlocated on the device body and configured to measure pressure in atleast one of the upper esophagus, lower esophagus, and stomach.
 6. Thedevice according to claim 5, wherein said at least one pressure sensorcomprises a pressure transducer.
 7. The device according to claim 1,further comprising at least one pH sensor carried by the device body. 8.The device according to claim 1, wherein said esophageal cuff isradio-opaque to aid in placement of the esophageal cuff at apredetermined location within the esophagus.
 9. The device according toclaim 1, further comprising a suction lumen formed within the devicebody and suction ports communicating with the suction lumen andconfigured to permit suction within the esophagus.
 10. The deviceaccording to claim 9, wherein said suction ports are configured asone-way valves to permit suction for emesis and/or reflux into thesuction lumen when a vacuum is drawn therethrough.
 11. The deviceaccording to claim 1, further comprising a sump port at the distal endand sump lumen formed the length of the device body and configured forventing gas and preventing adherence of the device against the gastricwall.
 12. The device according to claim 1, further comprising anebulizer lumen extending along the device body and comprising a portthrough which medication is delivered for administrating an involuntaryreflex cough test, wherein said esophageal cuff protects the airwayduring the involuntary reflex cough test.
 13. A system of diagnosing apatient for a physiological abnormality while protecting their airway,comprising a nasogastric/orogastric (Ng/Og) device, comprising: anelongate device body having a distal end for insertion into the stomachthrough the esophagus and a proximal end, and having a main lumenextending the length of the body and configured for at least one ofgastric decompression, enteral feeding and enteral medicationadministration; an expandable esophageal cuff carried by the device bodymid-esophagus and configured in a normally expanded position such thatwhen inserted within the esophagus the esophageal cuff conforms to theinterior surface of the esophagus and emesis and/or reflux is blockedfrom passing out of the stomach and past the esophageal cuff; and avacuum lumen carried by the device body and connected to the expandableesophageal cuff, wherein when vacuum is applied, the esophageal cuff iscontracted against the device body to permit the device to be insertedand placed within the esophagus, and when the vacuum is released, theesophageal cuff expands against the interior surface of the esophagus;at least one electromyogram (EMG) pad configured to be attached to thelumbar region of a patient's back and obtain an EMG from involuntarycough activated paraspinal muscles; and a processing device configuredto receive the EMG and process same to determine a physiologicalabnormality.
 14. The system according to claim 13, wherein the saidprocessing device comprises a portable device comprising, a housingconfigured for handheld use; at least one interface carried by thehousing and configured to receive any measurements obtained during theinvoluntary cough reflex test; and a processor carried by the housingand connected to the interface and configured to receive themeasurements.
 15. The device according to claim 13, wherein theexpandable esophageal cuff comprises a flexible sheath having an upperedge secured onto the device body.
 16. The device according to claim 15,further comprising an expandable balloon secured onto the device bodyunder the flexible sheath and attached thereto and a foam materialwithin the balloon that is compressed when vacuum is applied such thatthe flexible sheath contracts against the device body.
 17. The deviceaccording to claim 15, wherein the flexible sheath comprises a loweredge secured onto the device body and forming an expandable balloon, anda foam material within the balloon that is compressed when vacuum isapplied such that the flexible sheath contracts against the device body.18. The device according to claim 13, further comprising a nebulizerlumen extending along the device body and comprising a port throughwhich medication is delivered for administrating an involuntary reflexcough test, wherein said esophageal cuff protects the airway during theinvoluntary reflex cough test.
 19. A device to block emesis and/orreflux, comprising: a tube insertable within the esophagus; anexpandable esophageal cuff carried by the tube and configured in anormally expanded position such that when inserted within the esophagus,the esophageal cuff conforms to the interior surface of the esophagusand emesis and/or reflux is blocked from passing out of the stomach andpast the esophageal cuff; and a vacuum lumen carried by the tube andconnected to the expandable esophageal cuff, wherein when vacuum isapplied, the esophageal cuff is contracted against the tube to permitthe device to be inserted and placed within the esophagus, and when thevacuum is released, the esophageal cuff expands against the interiorsurface of the esophagus.
 20. The device according to claim 19, whereinthe expandable esophageal cuff comprises a flexible sheath having anupper edge secured onto the tube.
 21. The device according to claim 20,further comprising an expandable balloon secured onto the tube under theflexible sheath and attached thereto and a foam material within theballoon that is compressed when vacuum is applied such that the flexiblesheath contracts against the device body.
 22. The device according toclaim 20, wherein the flexible sheath comprises a lower edge securedonto the tube and forming an expandable balloon, and a foam materialwithin the balloon that is compressed when vacuum is applied such thatthe flexible sheath contracts against the tube.
 23. A method fordiagnosing a physiological abnormality in a patient, comprising:inserting a nasogastric/orogastric (Ng/Og) device through the esophagus,the device comprising an expandable esophageal cuff carried by thedevice body and a vacuum lumen carried by the device body and connectedto the expandable esophageal cuff; applying a vacuum within the vacuumlumen to contract the esophageal cuff against the device body to permitthe device to be inserted and placed within the esophagus; releasing thevacuum wherein the esophageal cuff expands against the interior surfaceof the esophagus and engages the esophageal wall to block emesis and/orreflux from the stomach passing into the esophagus past the valve toprotect a patient's airway during an involuntary reflex cough event;administering a nebulized medication to the patient to activate aninvoluntary reflex cough event; sensing a physiological condition of thepatient during the involuntary reflex cough event; and processing thesensed physiological condition that occurs during the involuntary reflexcough event to determine a physiological abnormality.
 24. The methodaccording to claim 23, further comprising sensing a physiologicalcondition by obtaining an EMG from involuntary cough activatedparaspinal muscles and further sensing intra-abdominal pressure (IAP)from a sensor carried by the device body and correlating the EMG and IAPwith the involuntary reflex cough event to determine a physiologicalabnormality.
 25. The method according to claim 24, further comprisingsensing pressure from a second pressure sensor carried by the devicebody and correlating the sensed pressure from the second sensor with theEMG and IAP.
 26. The method according to claim 23, further comprisingsensing pH from a pH sensor carried by the device body and correlatingthe sensed pH with the EMG and IAP.
 27. The method according to claim23, wherein the expandable esophageal cuff comprises a flexible sheathhaving an upper edge secured onto the device body.
 28. The methodaccording to claim 24, further comprising an expandable balloon securedonto the device body under the flexible sheath and attached thereto anda foam material within the balloon that is compressed with vacuum isapplied such that the flexible sheath contracts against the device body.29. The method according to claim 24, wherein the flexible sheathcomprises a lower edge secured onto the device body and forming anexpandable balloon, and a foam material within the balloon that iscompressed when vacuum is applied such that the flexible sheathcontracts against the device body.